Senior Clinical Operations SME
Overview
LMI is seeking a Senior Clinical Operations SME to support the Biomedical Advanced Research and Development Authority (BARDA). This position can likely be performed remotely. This position requires the ability to obtain a public trust clearance. You must be a U.S. citizen.
The Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers, immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, software, Assay chemistry, microbiology, virology, immunology.
LMI is a consultancy dedicated to powering a future-ready, high-performing government, drawing from expertise in digital and analytic solutions, logistics, and management advisory services. We deliver integrated capabilities that incorporate emerging technologies and are tailored to customers’ unique mission needs, backed by objective research and data analysis. Founded in 1961 to help the Department of Defense resolve complex logistics management challenges, LMI continues to enable growth and transformation, enhance operational readiness and resiliency, and ensure mission success for federal civilian and defense agencies.
LMI has been named a 2024 #BestPlacestoWork in the United States by Built In! We are honored to be recognized as a company that values a people-centered culture, and we are grateful to our employees for making this possible!
Responsibilities
- Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.
- Serve as an internal project manager/clinical team leader monitoring, assessing, and course-correcting contractors and vendors.
- Prepare and manage timelines, budgets, and other key deliverables.
- Develop and implement risk assessment and mitigation strategies.
- Ensure regulatory processes and guidelines are followed, includingco-authoring, and reviewing regulatory submissions to the US Food and Drug Administration (FDA)
- Author, review, develop Request for Task Orders (RTORs) and evaluate Clinical Research Organization (CRO) proposals.
- Provide independent cost, resource, and timeline estimates when requested.
- Review and/or develop work products related to the development and management of clinical studies and programs within current and planned BARDA products in vaccine, therapeutic, diagnostics, and devices advanced development and acquisition contracts.
- Overall clinical operations oversight.
- Review of study specific documents, including invoices, with provision of output.
Qualifications
- Advanced degree(s) in medicine, nursing, pharmacy, biotechnology, or related field with commensurate experience(s)
- Minimum of ten 10 years clinical trial operations experience beyond advanced degree, including in registrational phase II/III trials and positions with graduated responsibilities, including executive level positions
- Specific experience in Clinical Research Organization, private research organizations, pharma, academia, or government
- Minimum of ten (10) years of relevant experience and expertise in diverse clinical study designs, including clinical studies that support product development as well as product adoption and implementation (e.g., pragmatic or RWE studies) and decentralized approaches
- Expertise around clinical trial innovation and knowledge around what would be needed to integrate new processes, technologies, and approaches into clinical studies
- Strong understanding of CRO and DCT organization landscape
- Knowledge of critical capabilities to execute clinical studies such as necessary quality systems, data management systems, laboratory facilities, etc.
- Preferred: experience in working in non-traditional clinical sites, such as retail pharmacies and clinics, urgent care centers, or telemedicine/at-home services
- Preferred: Knowledge of both the clinical/technical aspects of executing clinical studies as well as the business administration and drivers for successful execution of clinical studies
- Experience should ideally include supporting diverse DCT, pragmatic and RWE approaches in clinical trials and products under evaluation (e.g., vaccines, therapeutics, diagnostics/devices)
- Ability to obtain a public trust clearance. You must be a U.S. citizen.